BNF for children and formulations

Ian Costello

British National Formulary

Formulations

• Evidence for use of medicines in children is often limited

• Information available in many places

• Many original actives not licensed for use in children

• Suitable formulations not available

Options

• Lack of suitable formulationscrushing/segmenting tabletsdissolving dispersible tabletspowdersuse of injections orallycutting suppositoriesextemporaneous preparationuse of chemicals

Crushing tablets / Opening capsules / Powders

• Whole dose available?

• Health and safety risk ?– dust– cytotoxic– immunosuppressant– hormones– sensitising agent

Dissolving dispersible tablets

• Dissolve or disperse ?

• Volume of water or other vehicle ?

• Dose reproducibility– homogenous dispersion ?– size of oral syringe ?

Cutting suppositories or tablets

• Uniform dispersion ?

• What does score line mean ?

Imported products

• Supporting information must be in English

• Evaluate every supply

• Ensure formulation evaluated– excipients

Extemporaneous preparations

• Formulation– strength– vehicle/suspending medium– constituents

• Bioavailability

• Dose uniformity

• Stability

• Storage

• Manufacturing environment

Lack of suitable formulations

• Range of formulations available for the same drug– Clobazam suspension

• > 10 extemporaneous formulations

• Dose uniformity unknown– can vary by up to 30%

• Bioavialability unknown

Risk management issues

• Lack of familiarity with drug or formulation

• Quality of product

• Lack of supporting information– PIL– SPC

Risk

• Unlicensed medicines usually patient specific – nothing is standardised

• Strengths of liquids• Formulations of liquids• Doses

Clinical Governance

• GPs required to prescribe unfamiliar medicines

• Unsure how to – prescribe– strength and formulation– monitor

• Community pharmacists required to supply unfamiliar medicines – know what they are?– where to get them from?– specification details?– sufficient information to check Rx?– what information to provide?

• Errors have occurred

• Information often not readily available

• Routine safety check difficult

• Supplying pharmacist is responsible for quality and specification

Minimising risk and variation

• Agree specification with supplier

• Request documentation – certificate of analysis or conformity

• Evaluate labelling

• Provide consistent formulation and manufacturing method

• Reduce variability in formulation– particle size– uniformity of dose– quality

• Clear policy should be available– Prescribing– Purchase– Supply– Administration– Record keeping

• Detailing responsibility of– PCT– Trust– Prescriber– Pharmacist

• Only use when licensed alternative not available– Alternative licensed drug ?– Can a licensed product be used by another

route?– Can a product licensed in another country be

imported?

• Until appropriate, well characterised formulations are available for children– policies and procedures required– standardised across a locality– primary and secondary care